Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer

Recruiting

• Conditions: Myocarditis Due to Drug; Lung Cancer

• Registration Number: NCT06818149
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This study aims to investigate the clinical classification and outcome-related biomarkers of immune checkpoint inhibitor (ICI)-related myocarditis in patients with lung cancer.A total of 50 patients with ICI-related myocarditis will be enrolled, including 25 with severe/critical myocarditis and 25 with subclinical/mild myocarditis. Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury markers, iron metabolism-related markers, and immunological markers will be measured and compared between groups. Changes in biomarkers after treatment will also be assessed. Clinical information such as in-hospital mortality and 3-month survival rates will be integrated to develop a severity assessment model. This model aims to evaluate disease severity and prognostic risk accurately by combining biomarkers, enhancing their application in clinical management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study Start: 2025-01-30
• Status Verified: 2025-02
• Primary Completion: 2025-02-01
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Pathologically confirmed lung cancer and having received at least one dose of immune checkpoint inhibitor therapy;
• Clinically diagnosed with immune checkpoint inhibitor-related myocarditis;
• Aged 18 years or older;
• Voluntarily signed informed consent after being fully informed.

Exclusion Criteria

• Pregnancy or breastfeeding;
• Presence of severe underlying cardiovascular diseases or recent acute cardiac events (e.g., myocardial infarction, severe arrhythmia);
• Concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases;
• Inability to complete the required examinations and follow-ups specified in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive performance of the severity assessment model	Up to 3 months	The severity assessment model, constructed based on biomarker combinations, was evaluated for its predictive performance using indicators such as the ROC curve and AUC value. The model demonstrated a predictive performance with an AUC \> 0.75 at different time points, indicating a high predictive ability and validating its practical application in clinical risk stratification.
The correlation between the dynamic changes in biomarker combinations and disease severity.	Up to 3 months	By monitoring the dynamic changes in biomarker combinations at different time points (baseline, day 3, day 7, and before discharge), this study aims to evaluate the differences between the severe/critical group and the mild/subclinical myocardial injury group, and investigate their correlation with disease severity. Independent sample t-tests will be used to assess the differences between the two groups, assuming a moderate effect size (Cohen's d = 0.7) for biomarkers between the severe/critical and subclinical/mild immune checkpoint inhibitor-related myocarditis patients. If significant differences (p \< 0.10) in biomarkers are observed between the groups, these differences will serve as key indicators for stratified management of disease severity.

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	Up to 3 months	The rate of death occurring within the hospital during a patient's stay.
3-month survival rate	Up to 3 months	The 3-month survival rate will be defined as the proportion of patients alive 3 months after enrollment in the study.
Length of hospital stay.	Up to 3 months	The length of hospital stay will be recorded and analyzed in relation to biomarker combinations and model prediction results, providing additional data to support practical applications in clinical management.
Improvement in patients' symptoms.	Up to 3 months	Patients' symptom improvement (e.g., fatigue, dyspnea) will be recorded using the New York Heart Association (NYHA) Functional Classification and analyzed in relation to changes in biomarker combinations. This will provide insights into the potential application of biomarkers in predicting symptom improvement and disease severity.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China